Duration: 53 minutes
Demand for Highly Potent Active Pharmaceutical Ingredients (HPAPIs) is growing strongly, driven by a strong clinical pipeline in the oncology field.
Due to their high pharmacological activity, the development and manufacturing of HPAPIs requires specialized high containment facilities operated by experienced personnel, a strong HSE culture, and regulatory expertise, to ensure the safety of both patients and employees.
By nature, HPAPIs are often complex molecules needing special care and specialized technologies for multi-step synthesis and purification. The recent development of antibody-drug conjugates (ADCs) has created new challenges for HPAPI manufacturers.
In this webinar recording, we present the factors to consider for safe Highly Potent API handling, from development to scale-up and manufacturing, through some case studies based on our extensive experience in the ADC field (payloads and bioconjugation).
Why should you watch this webinar recording?
In this webinar, you will learn more about risk-based approach throughout HPAPIs manufacturing to ensure occupational safety and to deliver safe product for the patients:
- What are the risks related to HPAPI production and when can they occur?
- What information is required to assess the risks?
- How to reduce the risks at each stage: during development/ manufacturing?
- How can process design contribute to safer handling of HPAPIs?
- How does facility design contribute to safer handling of HPAPIs?
- Why is it not sufficient?
- How to ensure risk control over time?
Who should watch this on-demand webinar?
- R&D Process Chemists
- Process Engineers
- Managers/Supervisors (Production/R&D/Industrialization)
- CMC/Outsourcing Managers
- Quality Assurance / Quality Control Managers
- SHE Managers
Rachel De Luca, Site Director, Novasep-PharmaZell Le Mans, France
Rachel De Luca studied Chemical Engineering at the Imperial College of London and the Ecole Nationale Supérieure des Industries Chimiques (ENSIC) in France where she graduated in 1992. She has more than 25 years of experience in the equipment supply and the CDMO services for the pharmaceutical industry. After working for the INRS (French reference body for occupational risk prevention), she joined Novasep in 2001. She currently heads the Novasep-PharmaZell Le Mans site, specialized in the process development and manufacturing of HPAPIs, & more recently, bioconjugation.
Bertrand Cottineau, Ph.D., P&D group head, Novasep-PharmaZell Le Mans, France
Bertrand Cottineau received his Ph.D. degree in organic chemistry at Orleans University in 2002. He has more than 15 years’ experience in process development for API and contributed to 9 scientific publications in international journals. He joined Novasep Le Mans in 2013 to lead the HPAPI process development group and is now responsible for both HPAPI and bioconjugation process development groups.